BRONZ REPAIR SEA AND TROPICS FACE SPF 25- octinoxate, avobenzone cream 
Naos USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BRONZ REPAIR SEA AND TROPICS FACE SPF 25

Drug Facts

Active Ingredients

Octinoxate 6%

Avobenzone 2.6%

Purpose

Sunscreen

Uses

  • Help prevent sunburn.

Warnings

For external use only.

Do not use

on broken skin.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

rash occurs

Keep out reach of children.

If swallowed, call a poison control centre or get medical help right away.

Directions

Adults 18 years and older:

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating
  • Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.; and
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.

Other information

  • Keep the product between 15-30ºC (59-86ºF).
  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water, Dicaprylyl Carbonate, Ethylhexyl Methoxycrylene, Glyceryl Stearate, Glycerin, Dipropylene Glycol, Peg-100 Stearate, Cyclopentasiloxane, Cetyl Alcohol, Methyl Methacrylate Crosspolymer, Cera Alba/Beeswax / Cire D'abeille, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-cresol, Oryzanol Creatine, Fragrance (Parfum), Glycyrrhetinic Acid, Mannitol, Methylpropanediol, Oryza Sativa (Rice) Bran Oil, Pentylene Glycol, Pongamol, Butylene Glycol, Trilinolein, Caprylyl Glycol, Xanthan Gum, 1,2-hexanediol, Acetyl Tyrosine, Aspartic Acid, Cerium Oxide, Potassium Cetyl Phosphate, Helianthus Annuus (Sunflower) Seed Oil, Polyethylene, Disodium Edta, Hydrogenated Castor Oil, Sodium Dextran Sulfate, Polysilicone-11, Sodium Hydroxide, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Potassium Sorbate, Triolein, Tripalmitin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydrolyzed Wheat Protein, Oleic Acid, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Medicago Sativa (Alfalfa) Extract, Trilinolenin, Phenoxyethanol, Propylene Glycol, Alcohol, Carbomer, Sodium Lactate, Tristearin, Tris(Tetramethylhydroxypiperidinol) Citrate, Polysorbate 20, Copper Gluconate, Bht, Asiaticoside, Artemia Extract, Madecassic Acid, Carnosine, Tocopherol, Asiatic Acid, Triarachidin, Disodium Adenosine Triphosphate, Laminaria Digitata Extract, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Acetyl Hexapeptide-1, Dextran, Red 33 (CI 17200), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Limonene, Benzyl Benzoate, Geraniol, Citronellol, Isoeugenol, Coumarin, Citral..

Question?

Call 1 877 443 3762

Package Labeling:

Outer Label5Inner Label5Label5

BRONZ REPAIR SEA AND TROPICS FACE SPF 25 
octinoxate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WHITE WAX (UNII: 7G1J5DA97F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
ENOXOLONE (UNII: P540XA09DR)  
MANNITOL (UNII: 3OWL53L36A)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
WHITE RICE (UNII: A195V20H7A)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PONGAMOL (UNII: 8Y19QCY6I4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRILINOLEIN (UNII: V5LJ52OGS7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
N-ACETYLTYROSINE (UNII: DA8G610ZO5)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
CERIC OXIDE (UNII: 619G5K328Y)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
OLEOYL TYROSINE (UNII: 131P1BQX1U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
GLYCERYL TRIOLEATE (UNII: O05EC62663)  
TRIPALMITIN (UNII: D133ZRF50U)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
OLEIC ACID (UNII: 2UMI9U37CP)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
ALFALFA (UNII: DJO934BRBD)  
TRILINOLENIN (UNII: OI7S0A9873)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
TRISTEARIN (UNII: P6OCJ2551R)  
TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
COPPER GLUCONATE (UNII: RV823G6G67)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ASIATICOSIDE (UNII: PKO39VY215)  
MADECASSIC ACID (UNII: M7O1N24J82)  
CARNOSINE (UNII: 8HO6PVN24W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ASIATIC ACID (UNII: 9PA5A687X5)  
TRIARACHIDIN (UNII: 48RPR95FW8)  
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
CYCLOHEXYL CINNAMATE (UNII: 2955WP594O)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
BENZYL BENZOATE (UNII: N863NB338G)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
ISOEUGENOL (UNII: 5M0MWY797U)  
COUMARIN (UNII: A4VZ22K1WT)  
CITRAL (UNII: T7EU0O9VPP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-015-001 in 1 BOX01/31/201808/31/2022
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/31/201808/31/2022
Labeler - Naos USA, Inc. (080727572)

Revised: 10/2022
 
Naos USA, Inc.